Preemptive Pricing

08/21/2009 12:09 PM |

The 8th U.S. Circuit Court of Appeals has rejected Iowa’s plan to offer brand-name medicines to Medicaid patients when it can get them at a lower price through government rebates.

In its ruling, the 8th Circuit noted that the U.S. secretary of Health and Human Services in 2007 "expressly rejected Iowa's approach" when he issued new federal limits on brand-name versus generic drugs.

That’s unfortunate since it will lead to Iowa having to spend about $1,000,000 more on drug costs.  But what’s really intriguing is the language the court used to justify it’s decision:

"Iowa now invites this court to second-guess the agency's expertise by attacking the policies underlying CMS's decision," the court wrote in its ruling. "However appealing Iowa's approach may appear to be as a matter of policy, we must give CMS the deference it is owed as a matter of law."

So there is preemptive authority when it comes to pricing – but their isn’t preemptive authority when it comes to safety?  An unfortunate allegory akin to health reform really being abot cost containment rather than patient care.

The complete story can be found here.

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Henry Waxman to play the role of Columbo

08/20/2009 01:36 PM |

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Media Matters: Where the truth matters not

08/20/2009 01:27 PM |

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A Public Plan? Just Say No.

08/20/2009 12:19 PM |

Is a public health insurance option essential?  Only if we want healthcare reform to fail in Congress and flounder in practice. Rather than turning Uncle Sam into Uncle Sam, MD, we should learn from history and build on the success of Medicare Part D - the prescription drug benefit for senior citizens.  Part D is the largest health entitlement program since Medicare was signed into law in 1965.  It has a 90% + approval ratings among its users and the projected cost for the program is $117 billion lower over the next decade than experts estimated. When it comes to the federal government providing healthcare to millions of Americans- it can be done with satisfaction and budgetary prowess.

How?  By adhering to free market principles.  The success of Part D is due to its uniquely American hybrid nature. The federal government partnered with the pharmaceutical and insurance industries to offer senior citizens healthcare choice via free market competition.  Rather than a one-size-fits-all government plan, Part D offers dozens of private sector plans offering Medicare-eligible Americans various options that best suit their personal healthcare situations. Uncle Sam doesn't design the programs or process the claims or dictate the formularies. Uncle Sam writes the check and sets the ground rules so that everyone has access to the medicines they need.  And the same can happen for access to health insurance - but only when we purge ourselves of the notion of the "essential nature" of a "public" plan.  Read More & Comment...

Words have Meaning

08/19/2009 02:35 PM |

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The Big Search Engines that Shouldn't

08/19/2009 01:32 PM |

In April 2004 (when I was an associate commissioner at the FDA), I met with representatives of the major credit card companies.  The focus of these meetings was on how their transactional services were being used to facilitate illegal internet prescription drug deals.  I was roundly denounced by, among others, Wisconsin Governor Jim Doyle, as using “hardball tactics" to stop traffic in low-cost prescription drugs from Canada.”  Political rhetoric aside, it was all about safety.

As it is today. 

According to a story in today’s Financial Times, Search engines pressed over drug ads policy,

“Pressure is building on the major US search engines to stop showing advertising from overseas drug sellers that deliver potentially counterfeit and dangerous products to consumers in violation of federal laws. The US Drug Enforcement Administration and the Food and Drug Administration are concerned that the practice is continuing despite the deaths of consumers who ordered drugs without examination by a doctor.”

It was the right thing to do in 2004 and it’s the right thing to do now. 

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Another Canadian Health Care Horror Story

08/19/2009 02:13 AM |

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So-called Health Care Reform a Real Laffer

08/19/2009 02:10 AM |

• The private sector has been slowly funding less and less of the total national health expenditures; as of 2007 less than 54 percent of total national health care expenditures are paid for by the private sector.
• Reciprocally, the public sector has been slowly funding more and more of the total national health expenditures; as of 2007 public expenditures at the federal and state levels now fund nearly one-half of the total health care expenditures in the U.S.
• Total out-of-pocket expenditures have been plummeting as a share of total health expenditures at an even faster rate; today only a bit more than $1 out of every $10 spent on health care is being funded by individuals through out-of-pocket expenditures.

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Today's Lettre de Cachet

08/18/2009 12:09 PM |

In keeping with President Obama’s request that patriotic Americans call out those who are spreading misleading information about healthcare reform, I must call out none other than New York Times columnist, Bob Herbert.

In his column today, “This is Reform?”,  Mr. Hebert writes about “the deal” struck between the White House and the research-based pharmaceutical industry, He writes, “To get a sense of how sweet a deal this is for the drug industry, compare its offer of $8 billion in savings a year over 10 years with its annual profits of $300 billion a year.”

A few points of clarification.  

First of all, the net annual profit of the top 20 innovator pharmaceutical companies is about $110 billion.  Anyone who pays taxes knows the difference between gross and net, so it’s not unfair to ask if Mr. Herbert was trying to be purposefully misleading.

Second, that same industry invests $60 billion a year in research and development.  A fact entirely absent from Mr. Herbert’s analysis.

And, finally, Mr. Herbert omits the fact that on-patent pharmaceuticals represent about only 8% of our entire national healthcare spend.  8 cents on the healthcare dollar.

Madame Defarge, take note and keep knitting.

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Self-Determination vs. Public "Option"

08/17/2009 03:45 PM |

I was in Atlanta where I was part of America's Health Care Town Hall.  The event ran from 1-4 pm and was up against 95 degree heat, a major hair stylist show, a nationally televised Phillies-Braves game and a Paul McCartney concert about four blocks away.

That's competition for you.

12,000 people showed up. 

They were not angry or unAmerican or part of any lunatic fringe group as Speaker Pelosi would have it.  They were not evilmongers as Senator Reid claims they are.

They were friendly, happy and well-informed about the health care bills pending in Congress.  They were not bitter or clinging to guns.  They had a dry sense of humor as many of the signs suggested.  Obamacare Rx.. " Take two Tylenol and call me when you're dead"(When I was on stage and told the assembled I was Yankee fan, they booed me.  One of the participants reminded me this was a pro-NRA crowd....)

And they had or have their own ideas about how to fix health care, combination of an insistence that no one be left behind,  America's cutting edge science with self-determination:

1.  Get rid of the public plan. 
2.  Eliminate any vestige of government bureaucrats deciding what is valuable or wasteful or cost-effective.
3.  Let people create their own health networks and buying groups around what is best for them based on patient-centered needs and outcomes. 

It's our money, our lives, our choices.  We have given up too much control to government over decisions too important for far too long.

Time to take back control.  

The arrogant effort of a liberal elite to centralize control over the practice of medicine and the capitulation of "stakeholders" in that effort have triggered among many an awakening that health care is a decision we have left in the hands of people and organizations that do not have our interests at heart. 

Simply modifying the public "option" will not do.

Only self-determination will suffice. 

That's what I learned from my fellow Americans in Atlanta.

Read more about the Atlanta Health Care rally here.

Here is a picture of me with extremely poor posture...

Video footage of the rally can be viewed here.
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When the Truth Hurts

08/17/2009 12:25 PM |

Interesting op-ed in Daily Mail by British columnist Stephen Glover.  The title says it all:

I deeply resent the Americans sneering at our health service  -  but perhaps that's because the truth hurts

Here’s how it begins:

"President Barack Obama's political enemies are rounding on his controversial proposals to extend government involvement in health care. One way in which they are doing so is to hold up our own cherished NHS for ridicule."

And here’s how it ends:

"The President is discovering that people are apt to want to defend and preserve what they have. The same is true of we British and our lumbering health service. The difference, though, is that what the Americans have is, for the most part, better than the NHS."

And here’s a link to the complete article.

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Personalized Pee Value

08/17/2009 12:05 PM |

A urine test could help doctors decide which drugs will be most effective for their patients, scientists have shown.In trials the test predicted how well men would respond to paracetamol. The experts from Imperial College London and the drug giant Pfizer report their findings in Proceedings of the National Academy of Sciences.

The researchers say this kind of "metabolic profiling" could ultimately allow doctors to work out perfect drug matches for individuals, with no risk of side effects. "Pre-clinical studies had suggested it might be possible to predict how individuals would react to drugs by looking at their pre-dose metabolite profiles, but this is the first time that anyone has been able to show convincingly that such a test could work in humans.

"The beauty of the pre-dose metabolite profiling is that it can tap into both genetic and environmental factors influencing drug treatment outcomes."

The full BBC story can be found here. 

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Alta in the Family

08/17/2009 11:57 AM |

When I was asked to advise President Obama’s FDA transition team, some of the smartest questions came from Alta Charo.  Now she can ask even smarter questions from the inside. Starting on August 31^st, she’s joining FDA as a senior advisor, reporting to Assistant Commissioner for Policy David Horowitz.

Charo (a professor of law and bioethics at the University of Wisconsin at Madison) also served on the Institute of Medicine panel that examined the country's drug safety system.  According to the Pink Sheet, “Other issues that Charo has examined include direct-to-consumer advertising and generic testing, and she has also come out in favor of a mandatory vaccination campaign for human papilloma virus.”

Charo told colleagues in Madison that she will be joining "a small group of people who will form a think tank within the commissioner's office." FDA declined to discuss what her exact role will be. Her appointment at the agency lasts for one year but can be renewed for another year.

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Spikes Speak

08/14/2009 11:53 AM |

AARP?  Fish or Foul?  Advocacy Organization or Insurance Company?  For HR3200 or Against ... or Agnostic?

See what Lou Dobbs has to say -- with some help from your's truly.

Click here ... and watch where you sit.



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Feel the Burn

08/13/2009 09:07 PM |

On the Fox program, “Money for Breakfast,” I was asked if America is suffering from “healthcare fatigue."  Short answer – no.  And that’s a good thing.

Here's a link to the short segment.

Not fatigued -- empowered!


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Health Care Headlines from Elsewhere in the World

08/13/2009 03:34 PM |

Foreign Affairs

As an antidote to the American media’s near-myopia about health care in considering the UK and Canada the only foreign countries with any relevance (which has abated somewhat but not nearly enough), some health care headlines from elsewhere in the world.

In Germany, in new poll by the Allensbach Institute indicates that the population is concerned about two-class medicine, with 72 percent of participants saying they are concerned that patients with private insurance get better treatment than those in the public system. And 80 percent of doctors say they don’t have enough time with patients to complete everything they need to.

Further, public sickness funds face deficits next year that are estimated at between 7 and 11 billion euros. Special “ancillary premiums” are likely to be charged by the sickness funds at some point this year and the insurers are seeking, unsuccessfully so far, more money from the government.

In France, the coffers of the national health care system are 9.4 billion euros in the red and conservative politicians there have been making ominous pronouncements about the future of the Sécurité Sociale system as a whole.

In Switzerland, health care premiums could rise up to 20 percent next year. A poll found that some 30 percent of people there may switch insurance companies if premiums go up 10 percent, some 43 percent if they increase 15 percent, and a majority will move to a cheaper company if the rise is indeed 20 percent. In addition, 58 percent say they are against the 30 Swiss franc (~$27) co-pay for visits to the doctor.

Deficits, co-pays, and too short consultations with the doctor. If this all sounds familiar, it should. The US isn’t alone in its problems and no system is perfect, all make trade-off with regard to what they cover and what they cost. All three of the above systems are either private or public-private hybrids that bear lots of similarities to the US system –and to American reform proposals, making it clear that no matter what the outcome of the bills now before Congress, the challenges the US faces aren’t going to magically melt away.

There are no panaceas in either policy or medicine and those who believe there are have been duped. The lesson is clear: look before you leap –and look carefully.

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Daniel in the Lion's Den

08/12/2009 12:27 PM |

Word today is that Dan Schultz is leaving his post as CDRH director and retiring from the FDA.

That's a loss.

Dan's smart, feisty, and calls it like he sees it -- a trait that has often put him at odds with lesser mortals.

And he's a nice, decent guy. Two traits often in short supply.

Good luck and God's Speed Dan Schultz.
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Lovenox Labors Lost

08/12/2009 12:07 PM |

A few years ago I met Israel Markov, the "Big Abba" of Teva.  A memorable guy for a lot of reasons.  One of those reasons was his blunt Sabra honesty.  One thing he said to me was that "Teva isn't in the pharmaceutical business.  We are in the litigtation business."

It seems now that another company, Amphastar Pharmaceuticals, isn't satisfied with patent litigation as its weapon of choice.  Unsatisfied with the way the FDA is dealing with their file for generic Lovenox, they've achieved new lows by attempting personal intimidation tactics.  It won't work.

They're slinging mud.  It will only come back to splatter on their own reputation.  

Amphastar claims that its rival, Momenta,  has a "leg up" and is getting "special access."  And yet both companies are in the same place in the regulatory process and both companies are being asked for the same data sets.  And this is unfair why?

According to Amphastar it's unfair because CDER Director, Dr. Janet Woodcock co-authored a paper with one of Momenta's founders, MIT biological engineering professor Ram Sasisekharan, on how the FDA taskforce (on which they both served) identified and contained the cause of contaminated Chinese heparin imports.

Talk about desperate measures.
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The AP Obama Apology Tour

08/11/2009 04:18 PM |

 Just so you know... From the latest AP editorial on heatlhcare

"His approval ratings slipping, President Barack Obama is retooling his message on health care overhaul, aiming to win over Americans who already have insurance."

Wait a minute.  I thought the goal of reform was to cover people who did not have insurance and couldn't afford it or were denied coverage.  Shouldn't the proposal be retooled as opposed to the message?

"Republicans say the heated debate is a sign of widespread public dissatisfaction with Obama's ideas. But with some of the anxieties spilling into angry disruptions and even threats, Democrats have accused Republicans of orchestrating the events to sabotage legislation. In an article published Monday, House Speaker Nancy Pelosi and Majority Leader Steny Hoyer wrote, "Drowning out opposing views is simply un-American."

Obama and his aides stayed away from such provocative language"

Right, they just set up a government website to collect information about political opposition and promising congressional Democrats that they would "punch back twice as hard" against opponents.  http://www.politico.com/news/stories/0809/25891.html

Do they address the major flaws and impact of every proposal on the table.

No.

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Deal or No Deal?

08/11/2009 12:00 PM |

Last night CBS News reported, "When he was running for President, Barack Obama attacked pharmaceutical companies for charging too much for prescription drugs. But now he's teamed up with those same companies to promote his healthcare plan," and critics are accusing President Obama "of making a back-room deal that could end up costing seniors plenty." CBS added, "Initial reports said the White House agreed not to seek price controls on drugs for seniors on Medicare and would not support importing cheaper drugs from Canada. Both the White House and the pharmaceutical industry now dispute that." CBS also noted that news of the "back-room deal riled fellow Democrats."

So, no deal?

But on August 5th, the New York Times ran a front page article headlined,

"White House Affirms Deal on Drug Cost.”

It read in part, “Mr. Tauzin said the White House had tracked the negotiations throughout, assenting to decisions to move away from ideas like the government negotiation of prices or the importation of cheaper drugs from Canada. The $80 billion in savings would be over a 10-year period. “80 billion is the max, no more or less,” he said. “Adding other stuff changes the deal.” After reaching an agreement with Mr. Baucus, Mr. Tauzin said, he met twice at the White House with Rahm Emanuel, the White House chief of staff; Mr. Messina, his deputy; and Nancy-Ann DeParle, the aide overseeing the health care overhaul, to confirm the administration’s support for the terms. “They blessed the deal,” Mr. Tauzin said. Speaker Nancy Pelosi said the House was not bound by any industry deals with the Senate or the White House. But, Mr. Tauzin said, “as far we are concerned, that is a done deal.”

So, deal?

Simple yes-or-no question:  Does the President support "the deal" or does he not?

 

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